title: Medication adherence assessment: high accuracy of the new Ingestible Sensor System in kidney transplants.
abstract: BACKGROUND
  This open-label single-arm exploratory study evaluated the accuracy of the Ingestible Sensor System (ISS), a novel technology for directly assessing the ingestion of oral medications and treatment adherence.
  
  
  METHODS
  ISS consists of an ingestible event marker (IEM), a microsensor that becomes activated in gastric fluid, and an adhesive personal monitor (APM) that detects IEM activation. In this study, the IEM was combined to enteric-coated mycophenolate sodium (ECMPS). Twenty stable adult kidney transplants received IEM-ECMPS for a mean of 9.2 weeks totaling 1227 cumulative days.
  
  
  RESULTS
  Eight patients prematurely discontinued treatment due to ECMPS gastrointestinal symptoms (n=2), skin intolerance to APM (n=2), and insufficient system usability (n=4). Rash or erythema due to APM was reported in 7 (37%) patients, all during the first month of use. No serious or severe adverse events and no rejection episode were reported. IEM detection accuracy was 100% over 34 directly observed ingestions; Taking Adherence was 99.4% over a total of 2824 prescribed IEM-ECMPS ingestions. ISS could detect accurately the ingestion of two IEM-ECMPS capsules taken at the same time (detection rate of 99.3%, n=2376).
  
  
  CONCLUSIONS
  ISS is a promising new technology that provides highly reliable measurements of intake and timing of intake of drugs that are combined with the IEM.
authors.affiliation: Division of Nephrology, Inselspital, Bern, Switzerland. ute.eisenberger@uk-essen.de
authors.forename: Ute
authors.initials: U
authors.lastname: Eisenberger
authors.forename: Rudolf P
authors.initials: RP
authors.lastname: Wüthrich
authors.forename: Andreas
authors.initials: A
authors.lastname: Bock
authors.forename: Patrice
authors.initials: P
authors.lastname: Ambühl
authors.forename: Jürg
authors.initials: J
authors.lastname: Steiger
authors.forename: Allison
authors.initials: A
authors.lastname: Intondi
authors.forename: Susan
authors.initials: S
authors.lastname: Kuranoff
authors.forename: Thomas
authors.initials: T
authors.lastname: Maier
authors.forename: Damian
authors.initials: D
authors.lastname: Green
authors.forename: Lorenzo
authors.initials: L
authors.lastname: DiCarlo
authors.forename: Gilles
authors.initials: G
authors.lastname: Feutren
authors.forename: Sabina
authors.initials: S
authors.lastname: De Geest
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013608:Tablets, Enteric-Coated
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid